On February 24, 2025, Deputy Head of the State Service of Ukraine on Medicines and Drugs Control Volodymyr Korolenko presented a public report on the results of the authority's activities in 2024.
In his presentation, Volodymyr Korolenko mentioned that for the third consecutive year since the start of the full-scale war, the State Service of Ukraine on Medicines and Drugs Control has maintained its critical work of ensuring and controlling the quality of medicines in the Ukrainian pharmaceutical market, licensing and certifying economic entities, and monitoring their compliance with licensing conditions.
Inspectors of the State Service of Ukraine on Medicines and Drugs Control work not only in relatively safe regions, but also in the frontline areas, in places where there is a high risk of missile attacks. Therefore, during air raids and rocket attacks, SMDC employees often have to continue working in bomb shelters of enterprises.
Volodymyr Korolenko informed the audience about the key performance indicators of the State Service of Ukraine on Medicines and Drugs Control in 2024.
The State Service of Ukraine on Medicines and Drugs Control has repeatedly initiated the cancellation of the moratorium on conducting planned and unscheduled state control measures regarding inspections of compliance by pharmaceutical market operators with the requirements for ensuring the quality of medicinal products and compliance by business entities with the requirements of license conditions. In recent years, the State Service of Ukraine on Medicines and Drugs Control has prepared a number of draft government resolutions amending Resolution of the Cabinet of Ministers of Ukraine No. 303 dated 13.03.2022. The draft amendments were also discussed with business and public organizations, which were sympathetic and supportive of the State Service of Ukraine on Medicines and Drugs Control's initiatives to fully resume inspections and state market surveillance measures.
Therefore, one of the main achievements is the adoption of Resolution of the Cabinet of Ministers of Ukraine No. 1264 dated 05 November 2024 “On Amendments to Resolution of the Cabinet of Ministers of Ukraine No. 303 dated 13 March 2022”, according to which, starting from 01 January 2025, the State Service of Ukraine on Medicines and Drugs Control resumed planned inspections of the legislative requirements on the medicines quality and compliance with the license conditions by business entities in the pharmaceutical market and in the field of circulation of narcotic drugs, psychotropic substances and precursors.
Due to the adopted legislative amendments, in January 2025, the State Service of Ukraine on Medicines and Drugs Control conducted about 80 planned and 3 unscheduled inspections of business entities for compliance with the requirements of the legislation on the medicines quality and license conditions. Based on the results of all inspections, violations were found, and most of them were detected during planned inspections!
Volodymyr Korolenko also focused on the general tendencies of the national pharmaceutical market during martial law.
Thus, despite the extremely difficult situation, our pharmaceutical market demonstrates positive dynamics in terms of restoring the number of pharmacies and the number of licensees for e-retail of medicines is growing.
In January 2024, the first mobile pharmacy started its work in Kharkiv region, with a route that included 86 settlements. As of February 01, 2025, the Register of Mobile Pharmacy included 30 units from 15 regions of Ukraine, with routes covering about 1000 rural settlements.
In 2024, the Law of Ukraine No. 3528-IX dated 21 December 2023 “On Amendments to Certain Laws of Ukraine on State Regulation of the Circulation of Cannabis Plants” was put into effect. The State Service of Ukraine on Medicines and Drugs Control has developed six governmental resolutions to implement this law.
In October last year, the Electronic Cannabis Accounting Information System was launched. The owner, administrator of the electronic system and the owner of its information is the state represented by the State Service of Ukraine on Medicines and Drugs Control. All operations with medical cannabis (from the purchase of plant seeds to the waste disposal) are strictly controlled and entered into the Electronic Cannabis Accounting Information System.
In total, during the past year, the State Service of Ukraine on Medicines and Drugs Control developed, processed and coordinated with the relevant state authorities more than 40 draft regulatory acts.
Last year, the State Service of Ukraine on Medicines and Drugs Control continued to participate in the adaptation of national sectoral legislation to EU requirements and standards - European integration processes are ongoing.
Another important event in 2024 was the adoption of the Communication Strategy of the State Service of Ukraine on Medicines and Drugs Control for 2024-2029, which was developed as part of the implementation of the National Strategy for Creating a Barrier-Free Environment in Ukraine, taking into account the recommendations of the Barrier-Free Events Guide, in accordance with the initiative “No Barriers” of the First Lady of Ukraine Olena Zelenska.
In conclusion, Volodymyr Korolenko expressed gratitude to his colleagues for fruitful cooperation in 2024 and wished them effective teamwork this year.
Caring for the public health is our main goal!